Heart Failure, CongestivePhase 2NCT00234104

A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)

A Phase 2 study testing OPC-41061(Tolvaptan) in people with Heart Failure, Congestive and Edema, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at… Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Heart Failure, Congestive, Edema
What is being tested?: OPC-41061(Tolvaptan)
How many people: 122 participants
Where: 1 siteJapan
Study dates: Aug 2004to Jan 2006
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, pulmonary congestion, or 3rd sound due to extracellular volume expansion
Hospitalized patients or patients who can be hospitalized for the study from the commencement of the observation period to the end-of-study examination
Men and women between the ages of 20 and 80 (non-inclusive) at the time of giving consent
Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period
Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration

Who cannot join

Patients with unstable heart failure (acute heart failure, acute exacerbation of chronic heart failure, etc)
Patients with an implanted ventricular assist device
Patients who have undergone or are scheduled to undergo any of the following procedures
Heart surgery involving thoracotomy within 60 days prior to the screening examination
Pacemaker implant surgery involving bilateral pacing within 60 days prior to the screening examination
Angioplasty, electrophysiologic device implantation, ventricular assist device implantation, heart transplant, or other cardiac surgery scheduled within 30 days after the screening examination

Show all 33Show fewer

Patients with any of the following diseases, complications, or symptoms
Suspected hypovolemia
Onset of acute myocardial infarction within 30 days prior to the screening examination
Hypertrophic cardiomyopathy (excluding diastolic phase)
Definitively diagnosed active myocarditis or amyloid cardiomyopathy
Valvular heart disease with significant stenosis
Untreated thyroid disease
Progressive neurological disease (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc) or severe episodic neurological disease (epilepsy, Guillain-Barre syndrome, etc)
Diabetes with poor glycemic control
Anuria
Hepatic coma
Hyponatremia of moderate or greater severity (serum Na < 120 mEq/L)
Patients with a history of the following conditions
Occurrence of sustained ventricular tachycardia or ventricular fibrillation within 30 days prior to the screening examination (except for patients using an implantable cardioverter-defibrillator)
Evident cerebral infarction
Multiple stroke
Occurrence of a cerebrovascular accident within 30 days prior to the screening examination
Hypersensitivity or idiosyncratic reaction to benzazepine derivatives, such as benazapril
Patients with a history of drug abuse or alcoholism in the past year
Patients in a state of morbid obesity with a body mass index (weight[kg] ÷ height [m]2) over 35
Patients with a supine systolic arterial blood pressure of less than 90 mmHg
Patients with any of the following abnormal laboratory values: Hemoglobin <9 g/dL, total bilirubin >3.0 mg/dL, serum creatine >3.0 mg/dL, serum Na >147 mEq/L, or serum K >5.5 mEq/L
Patients not capable of taking oral medication
Patients who are nursing, pregnant, capable of pregnancy, or intending to become pregnant during or shortly after the study period
Patients who have taken a study drug other than OPC-41061 within 30 days prior to screening
Patients who have previously taken OPC-41061 in this study or another study of OPC-41061
Patients otherwise judged by the principal investigator or attending investigator to be inappropriate for inclusion in the study (eg, patients with hepatic cirrhosis, renal disease, etc.)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Otsuka Pharmaceutical Co., Ltd.
Tokyo

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion

Conditions: Heart Failure, Congestive, Edema
Being tested: OPC-41061(Tolvaptan)
Keywords: OPC-41061, Tolvaptan, Heart Failure, Edema, Extracellular volume expansion
Medical subject headings: Heart Failure, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-41061(Tolvaptan)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight
The body weight change from baseline following final trial drug administration
Measured: Baseline, at the time of final trial drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2004Jan 2006

First posted6 Oct 2005 (estimated)
Study startAug 2004
Primary completionJan 2006
Study completionJan 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00234104
Sponsor's protocol ID: 156-03-001
Other IDs: JapicCTI-050038
Status last verified: Nov 2013
First submitted: 4 Oct 2005
Last updated: 25 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Dose Response of OPC-41061 in Congestive Heart Failure Patients With Extracellular Volume Expansion
ClinicalTrials.gov ID: NCT00234104
Acronym / sponsor ID: 156-03-001
Conditions: Heart Failure, Congestive, Edema
Keywords: OPC-41061, Tolvaptan, Heart Failure, Edema, Extracellular volume expansion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2004
Primary completion: Jan 2006 (actual)
Study completion: Jan 2006 (actual)
First posted: 6 Oct 2005 (estimated)
Results: Posted 25 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, pulmonary congestion, or 3rd sound due to extracellular volume expansion
Hospitalized patients or patients who can be hospitalized for the study from the commencement of the observation period to the end-of-study examination
Men and women between the ages of 20 and 80 (non-inclusive) at the time of giving consent
Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period
Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration

Key exclusion criteria (33 listed)

Patients with unstable heart failure (acute heart failure, acute exacerbation of chronic heart failure, etc)
Patients with an implanted ventricular assist device
Patients who have undergone or are scheduled to undergo any of the following procedures
Patients with any of the following diseases, complications, or symptoms
Patients with a history of the following conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-41061(Tolvaptan)	Drug	–

Primary outcome

Body Weight
Time frame: Baseline, at the time of final trial drug administration
The body weight change from baseline following final trial drug administration

Results and safety

Results posted to the registry on 25 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	30	26
15 mg of OPC-41061	29	28
30 mg of OPC-41061	34	29
45 mg of OPC-41061	29	21

Primary outcome: Body Weight

Time frame: Baseline, at the time of final trial drug administration. Mean (Standard Deviation). Unit: Kg

Measure	Placebo n = 28	15 mg of OPC-41061 n = 28	30 mg of OPC-41061 n = 33	45 mg of OPC-41061 n = 28
Value	-0.53 (0.96)	-1.62 (1.55)	-1.35 (1.54)	-1.85 (1.10)

Placebo vs 15 mg of OPC-41061: Mean Difference (Final Values): -1.09, p = 0.0074, t-test, 2 sided
Placebo vs 30 mg of OPC-41061: Mean Difference (Final Values): -0.82, p = 0.0459, t-test, 2 sided
Placebo vs 45 mg of OPC-41061: Mean Difference (Final Values): -1.32, p = 0.0010, t-test, 2 sided

Population analysed: 1 Subject of Placebo arm who experienced a serious adverse event was excluded from efficacy analysis set because the emergency code was broken.

Adverse events

Time frame: 7 days. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 29 (13.8%)	14 of 29 (48.3%)	Not reported
15 mg of OPC-41061	0 of 28 (0%)	21 of 28 (75%)	Not reported
30 mg of OPC-41061	1 of 33 (3%)	25 of 33 (75.8%)	Not reported
45 mg of OPC-41061	2 of 28 (7.1%)	21 of 28 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heart Failure, Congestive

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katsuhisa Saito study director

Division of New Product Evaluation and Development

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPC-41061(Tolvaptan) in people with Heart Failure, Congestive and Edema, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (time frame: Baseline, at the time of final trial drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.